FDAFDA · Food and drugs·Recall number Z-2369-2021
Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
Published September 8, 2021 · Recall initiated: May 28, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien, LP
- Distributor
- Worldwide distribution.
- Lot
- Lot Numbers: 1925300162
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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